Home NDC 0597-0197 Praxbind
Product NDC 0597-0197
11-digit product format 005970197
Labeler code 0597
Product ID 0597-0197_9474d542-4726-4546-a768-10d418cdf5cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name idarucizumab
Dosage form INJECTION
Route INTRAVENOUS
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application BLA761025
Marketing category BLA
Marketing start 2015-10-21
Substance IDARUCIZUMAB
Active strength 50 mg/mL
Pharmacologic classes Antibodies, Monoclonal, Humanized [CS], Humanized Monoclonal Antibody Fragment [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Praxbind
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IDARUCIZUMAB 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 97RWB5S1U6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1716195 Internal RxNorm lookup 1716200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0197-05 Praxbind 2 in 1 CARTON INJECTION 2 8 0597-0197-05 Praxbind 50 mL in 1 VIAL, SINGLE-DOSE INJECTION 50 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0197 PRAXBIND (IDARUCIZUMAB) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240208_c7400f8a-dcf4-a6df-6d07-983081b1bf34.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Praxbind IDARUCIZUMAB Boehringer Ingelheim Pharmaceuticals, Inc. c7400f8a-dcf4-a6df-6d07-983081b1bf34 2024-01-23 Warnings, Adverse reactions Exact identifier application number: BLA761025 ndc (product): 0597-0197
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761025 Praxbind idarucizumab 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0597-0197-05 00597019705 2 VIAL, SINGLE-DOSE in 1 CARTON (0597-0197-05) / 50 mL in 1 VIAL, SINGLE-DOSE 2015-10-21 0000-00-00 No No Current